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Duloxetine in ADHD

Duloxetine vs Methylphenidate in adolescents with ADHD: A randomized trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT138810193029N1
Enrollment
30
Registered
2010-03-01
Start date
2009-12-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD. Disturbance of activity and attention

Interventions

Intervention 1: Duloxetine, 30-60 mg/day, starting dose 30 mg/day for 1 week and 60 mg/day for the following 5 weeks. Intervention 2: Methylphenidate, starting dose: 10 mg/ day divided in two doses fo
Treatment - Drugs
Duloxetine, 30-60 mg/day, starting dose 30 mg/day for 1 week and 60 mg/day for the following 5 weeks
Methylphenidate, starting dose: 10 mg/ day divided in two doses for 1 week and 20, 30 and 40 mg/day divided in 3 doses in weeks 2, 3 and 4 respectively according to the patient tolerance and continue

Sponsors

Tehran University of Medical Sciences and Health services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
11 Years to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Diagnosis of ADHD according to DSM-IV-TR Criteria, age range of 11 to 18 years Exclusion criteria: Presence of mental retardation, cardiac problems, known contraindications to study drugs, Comorbidity of severe major depression, conduct disorder, bipolar or psychotic disorders, epilepsy taking anticonvulsants at the time of enrollment and during the trial, pregnancy or lactation, refusal to participate

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
ADHD severity of symptoms. Timepoint: Baseline, Every 2 weeks, End point. Method of measurement: Conner's and ADHD rating Scale.

Secondary

MeasureTime frame
Drug side effects. Timepoint: every 2 weeks and end point. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Javad Mahmoudi-Gharaei

Tehran University of Medical Sciences

jmahmoudi@razi.tums.ac.ir+98 912 226 2590

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026